TEMPERATURE CONTROLLED LOGISTICS: STRATEGIES FOR THE … · temperature and humidity. The characterization of these synthesized human proteins in solution has shown a fragility that

1

TEMPERATURE CONTROLLED

LOGISTICS: STRATEGIES FOR

THE FUTURE

SPONSORED BY:

2

The future of the pharma cold chain logistics industry is in good shape, with sturdy growth being forecasted for the $12 billion market 1. Similar to the pharma industry it can, at times, be sluggish to evolve. Despite this, many experts are of the opinion that a range of trends are due to take hold in the industry. The rise of cell and gene therapies and the logistics paths they require (patient to manufacturer to patient, for instance) and the inherent sensitivity of the biomaterials will place new demands on the industry.

Gary Hutchinson noted that we are due to see packaging and network designs become more tailored for specific drugs. We are seeing a trend in pharmaceutical manufacturers beginning to design their cold chain networks specifically to the drug platform or modality based on therapeutical area. The ability to tackle a whole range of chronic diseases and illnesses with exciting new technologies has driven more and more specialization in not only the cold chain but the entire logistics network. For example, stable and better characterized drugs with an exemplary safety

FOREWORDrecord are using deferred shipping lanes, new transport modes including ocean freight, and an increased allowable range in shipping temperatures. However, more fragile platforms like a monoclonal antibodies require greater characterization of the drug product not only for temperature hazards, but a full range of environmental hazards including shock, vibration, temperature and humidity. The characterization of these synthesized human proteins in solution has shown a fragility that requires complex and specialized logistics networks supported by cushioning thermal packaging with tight control on temperature ranges. Coupled with the controlled temperature requirements for small molecule drugs, the depth and complexity of modern pharmaceutical supply chains will grow exponentially.

There are also new strategies appearing in terms of packaging conduct, payload volumetric efficiencies in packaging to leverage innovative techniques and metric calculations to maximise container utilisation. Also, some have been experimenting with the use of

multi-cell trailers—refrigerated trailers with insulated curtains hung at intervals to create different temperature zones. Some peer pharma firms in the industry have noted the value in cross-firm collaboration on shipments and lanes to improve efficiency instead of having vacant space shipped due to packaging size constraints. The global insulated packaging marked is due to mature at a rate of 5.68% CAGR to 2020, driven by demand from the pharma industry. 2

Experts are contemplating the impact that will be incurred on the cold chain by 3D Printed pharmaceuticals and the use of drones for delivery.

Pharma Logistics IQ presents the findings of its 2016 Temperature Controlled Logistics Future Trend Report, which examines the oncoming strategies likely to blossom in the cold chain industry.

3

In Q3 of 2016, Pharma Logistics IQ hosted an online

survey to assess current perceptions on how the cold

chain industry is likely to evolve over the next few years.

The survey gathered the responses of the

many stakeholders in the international cold chain

community.

ABOUT THIS SURVEY

Companies featuring in our respondent base include the likes of:

Eli Lilly and Company, Korea Astellas Pharma Inc. Ministry of Health - Morocco Ghana Health Service Novartis Marketsandmarkets Genentech

WHAT CATEGORY DOES YOUR COMPANY FALL IN TO?

Large pharma/bio manufacturer 11.4% Small-to-mid size pharma / manufacturer 9.1% Medical device manufacturer 5.7% Generics 2.3% Government 8.0% Solution provider 36.4% Other (please specify) 27.3% Pharmacy Products Distribution logistics provider Consulting Wholesale and distribution to the maritime sector Chilled Food Distributor Freight forwarder Market research Contract Research Organization API Manufacturer consultancy on cold chain warehouses

4

Pharma Logi IQ: It’s encouraging here to see that being

future proof is a priority for the majority of our respondents. Although just under 20% of those who responded noted that

there needs to be an improvement in regards to the focus applied on this area.

RESULTS FUTURE PROOFING

HOW IMPORTANT IS IT TO STRIVE TOWARDS BEING FUTURE PROOF AS A TEMPERATURE CONTROLLED LOGISTICS ORGANISATION ?

It is a prime priority for the business end-to-end 56.8%

There are a few members in the business who champion this aspect 17.0%

We have the right balance 4.5%

It requires more focus 17.0%

We are dangerously oblivious to its importance 2.3%

Other (please specify) 2.3%

It will work for us as partners

We provide the services in order to enable temperature controlled logistics

Pharma Logi IQ: Here quality and risk management take the

lead ahead of cost management. This is a positive trend as it indicates, that even though the industry has a focus on cost

management this does not supersede the importance of protecting quality levels and

mitigating risk.

WHAT AREA WILL BE THE MOST DAMAGING TO YOUR FIRM IF YOU DON’T ADAPT AND INNOVATE QUICKLY?

Compliance strategies 9.1%

Quality & risk management 42.0%

Product offering 11.4%

Creating a leaner the supply chain 8.0%

Cost management 20.5%

Accessing new markets 9.1%

Heather Bogle, Supply Chain Solutions Manager at Almac Group:

"Temperature services is a growing industry that many pharmaceutical

companies are increasingly embracing as a key priority in the business and this is

reflected with over 50% of companies listing this area as prime priority. Within the past

5 years, Almac has seen a 40% increase globally in temperature shipments and it is

becoming a trend that companies recognize is important to be an industry frontrunner.

Many companies are taking a proactive approach to the realm of temperature

controlled logistics rather than a reactive response to an inspection and audit findings.

I find it surprising to see that there is still over a third of companies responding that

this area needs more focus or that not many within their business champion this aspect. I

suspect that with details of inspection results and further clarification of the regulators

expectations throughout the next year we will begin to see a decrease."


“Patient Safety is the core focus of managing temperature compliance. It is not

surprising to see Quality rated as the area that could be most damaged and impacted if there is no adaptation within the temperature

services industry. Regulatory requirements change and the healthcare industry is

constantly growing; without continuous innovation to develop compliant offerings,

there will be great risk to patients as services and software will not evolve fast enough to

meet the industry’s changes.”

5

Pharma Logi IQ: Entering emerging markets is seen as a top

investment plan over the next 12 months which is to be expected due to the

forecasted rapid growth. However, as noted in research reports a key challenge

faced by cold chains operating through emerging markets is the high cost

of real estate and energy.

RESULTS

WHAT ARE YOUR INVESTMENT PLANS OVER THE NEXT 12 MONTHS FOR OPTIMISING TEMPERATURE CONTROLLED LOGISTICS?

Finding more efficient packaging suppliers 14.8%

Finding more innovative 3pls 20.5%

Locating more proficient data logging devices 14.8%

Partnering with more advanced freight forwarders 17.0%

Exploring for more developed airlines 9.1%

Searching for innovative sea freight providers 4.5%

Entering new emerging markets 19.3%

HOW IMPORTANT IS DATA FOR THE FUTURE OF YOUR FIRM’S PROGRESSION?

Vital 52.9%

Important 42.9%

Somewhat of interest 4.3%

FUTURE PROOFING


“Data capture and data integrity is what proves the quality,

integrity and safety of a product. Ongoing temperature monitoring during the

transportation of shipments is the only way to ensure the integrity of an IMP.

Utilizing a fully validated central system that captures and retains temperature data,

planned excursions, all linked to the product shipped, allows pharmaceutical companies

to adjudicate excursions efficiently and accurately to determine the safety of

the product for dispensation to patients. Accurate, accessible data ensures

patient safety.”

6

Pharma Logi IQ: Unsurprisingly, compliance ranks in the top 3 dominant pain points

for temperature controlled logistics, interestingly though; it is rated below

controlling cost. This signals that the industry is confident in the regulatory requirements expected of them. This is evidenced by the

fact that a vast minority see audits as the main pain point in their corporations.

RESULTS THE FUTURE & ITS PAIN POINTS

WHAT AREA WILL BE YOUR BIGGEST PAIN POINT OVER THE 12 MONTHS?Controlling costs in the supply chain 26.1%

Compliance 19.3%

Managing partnerships & stakeholder efficiency in the supply chain 17.0%

Challenges of emerging markets 13.6%

Upholding and managing quality measures- QMS 11.4%

Audits 6.8%

Being flexible to the impact of mergers and acquisitions on your temperature controlled supply chain. 5.7%

TOP 3 BLOCKS TO CHANGING PROCESSES OR OPTIMISING THEM QUICKLY

Lack of methodologies that enable rapid change

12.5%

Complexity of business operations

29.5%

Lack of resources

26.1%

1 2 3

Heather Bogle, Supply Chain Solutions Manager at Almac Group: “There is a general consensus to the

pain experienced by companies when they try to remain compliant with regulations but also mitigate costs. The challenge is always

whether this is a necessity to ensure patient safety or are we tracking and documenting data just to prove compliance for a low risk situation. The response highlights that it is

not easy, efficient or cheap to collect secure and sound data from multiple vendors and sources. There is a complicated balance to

achieve between cost effectiveness with minimal resources and regulations that are

not clear and constantly change. Keeping on the cutting edge with innovation, in line with regulatory compliance is the key. A flexible,

evolving platform that allows multiple shipping vendors and different brands of monitors is the only solution that doesn’t

break the bank.”

7


Pharma Logi IQ: Cost control appears as the dominant

pain point to navigate. Improving vaccine distribution in general is seen as a

significant hurdle that will increase in the next few years, likely due to the increasing

use of biotech and therapeutic biologics.


“Keeping up with the changing regulations that are different for each

country and each region across the globe continues to plague all of us. We are

seeing slow changes within the industry and global groups pushing to the forefront

to pull the different regions together and attempt to work towards a consensus. This is

encouraging however the jury is still out as it is too early to tell whether or not it will be

possible to achieve.”

WHAT WILL BE THE DOMINANT CHALLENGE FOR THE FUTURE OF SUPPLY CHAIN LOGISTICS? Improving vaccine distribution in emerging markets as well as more established markets 20.0%

Seafreight and meeting weight declaration regulations 4.3%

Products spoiling due to being left on the tarmac for extended periods in airports 18.6%

The pressure to drive down outgoings in the supply chain 21.4%

Compliance and quality management 35.7%

Pharma Logi IQ: The dominant challenge on validation aligns to the quality and risk

focuses mentioned earlier in the data. Interestingly one participant notes the focus

of tailor-making packing and distribution lanes to products as mentioned by some

thought leaders in the industry.

WHAT WILL BE THE DOMINANT CHALLENGE FOR THE FUTURE OF TEMPERATURE CONTROLLED PACKAGING?PCM liquid leakage 4.3%

Data loggers and temp controlled monitors malfunctioning 22.9%

Validation testing not being representative to real world use. 37.1%

Reducing the amount of ‘air-shipped’ in a container 15.7%

Abiding by the tight margins with CRT products 14.3%


Thermal insulation Designing flexible packaging and distribution planning for each product group

8


Pharma Logi IQ: Considering that the majority of our

participants noted that data is vital to the progression of their organisation, it

remains a slight concern that the biggest challenge in data management is the process of using the data effectively.

WHAT ARE YOUR MAIN DATA CHALLENGES?Organization not using data effectively 22.9%

Data is incomplete or incorrect 18.6%

Difficult to access data at point of process execution 21.4%

Data is kept in information siloes 7.1%

Inconsistent data definitions 10.0%

Returning of data loggers 5.7%

Malfunctioning data loggers 4.3%

Losing data loggers 5.7%


Need more data sharing between providers and users Defining the correct and effective positioning of monitors.

IN REGARDS TO THE EU UPDATE TO CLINICAL TRIAL REGULATION, DUE TO COME INTO FORCE IN 2017-2018, WHAT WILL BE THE BIGGEST HURDLE? Labelling requirements 5.7%

Reporting requirements 10.0%

Meeting transparency requirements 25.7%

Adapting to the single electronic entry point for applications – the EU portal 17.1%

Co-operation between manufacturers and sponsors 34.3%


Compliance It will have some effect


"It is clear from these results that determining what to do with data is still something being tackled by the industry. We have given in to the fact that collecting data is the only real way to show evidence of

compliance. However by the responses in the survey, we have not mastered organizing this into something that is useful within our companies. An opportunity is slipping through our fingertips as there are key

performance metrics for our suppliers and internal business process improvement suggestions hiding within the multitudes of numbers.

Another point highlighted is that unless you make it easy for the sites, you are fighting a losing battle. It is well known across the industry that sites do not always comply with protocol in uploading data to

applicable repositories and this results in companies turning into stalking the recipient to make a collection. Ensuring an easy site user experience to upload is vital, however there is still the human element factor

to keep in mind. Additional email reminders that only occur after proof of delivery have shown to be successful. These notifications can include additional contacts, for example CRA’s, which means the

issue can be addressed during the next monitoring visit."

9

RESULTS FUTURE TRENDS

WHAT DO YOU PREDICT WILL BE THE MOST DISRUPTIVE TECHNOLOGY FOR THE TEMPERATURE CONTROLLED SUPPLY CHAIN OVER THE NEXT DECADE?

WHAT WILL BE A KEY SUPPLY CHAIN LOGISTICS TREND TO CAPITALISE ON OVER THE NEXT FEW YEARS?

Added visibility from serialisation and track and trace programmes 31.4%

Unlocking emerging markets via innovative strategies 32.9%

Performance-based financing 5.7%

Driving toward greener solutions 12.9%

Cutting costs 14.3%


Digital Logistics

Merger of cold chain technologies with serialization technologies

DRONES 3D PRINTING PRECISION MEDICINE

BIOPHARMACEUTICALS HYBRID PACKAGING

DISPOSABLE DATA LOGGERS

10

Pharma Logi IQ: The application of stability budgets to better

strategize temperature control lanes is a discussion that we have seen come to the

fore recently, with some maintaining that the Time Out of Storage acquired from

the stablility budget should be left for the section after the last mile as the product

reaches consumption.

RESULTS FUTURE TRENDS

A KEY FUTURE TREND TO CAPITALISE ON IN TEMPERATURE MONITORING?

NAME A KEY TREND WHICH IS LIKELY TO EMERGE OVER THE NEXT FEW YEARS IN REGARDS TO TEMPERATURE CONTROLLED PACKAGING Use of bulk passive units 11.4%

Custom packaging solutions 32.9%

Volumetric efficiency analysis 8.6%

Multi-cell trailers 5.7%

Peer collaborations during shipments 12.9%

Hybrid packaging containers 12.9%

SKU Congruency within passive units 4.3%

Use of numerical models to adapt packaging 7.1%


Internet of Things

Combining and integrating devices from various vendors 24.3%

Visualising data via information dashboards powered by cloud solutions 32.9%

Use of stability data to direct supply chain strategies 34.3%

Disposable Data loggers 7.1%


Wireless Based Product Condition Monitoring


"Three key areas are seen to carry similar importance. Having a centralized

temperature database that can collect information from various vendors, various

monitors and provides a link to the stability profile of the product is the key. This

allows for the analysis of concepts, such as shipping lanes against excursion results,

trends of excursions in geographic areas and even trends in site compliance by country

or protocol. In addition, the flexibility of using any shipping vendor and any monitor

ensure you are not restricted to making a commitment to one partner and limiting

your options."

11

Cathy RobersonDrones are constantly in the news with the likes of Amazon, Wal-Mart, Facebook, Google and more testing them as delivery options. Imagine receiving a book you ordered via Amazon’s drone delivery service or perhaps a hard to find part for your classic car by way of Facebook’s drone delivery service. Depending on one’s location and need as well as lobbying efforts such as Amazon’s rumored spend to educate US government officials on a range of topics including this mode of travel; the future for drone deliveries is a reality.

For healthcare professionals, the use of drones has huge benefits in particular the ability to reach remote areas that lack proper infrastructure to deliver lifesaving drugs and other necessities. Many tests are underway to determine its viability but as one can imagine, it is under much government scrutiny and regulators in many countries

INDUSTRY COMMENTARY: DRUGS VIA DRONE DELIVERY – A VIABLE SOLUTION?

are working with the industry to develop requirements for the delivery and flying of drones.

Last year’s devastating earthquake in Nepal saw drones in action. Global Medic, a Canadian charity that provides disaster response in the form of medical assistance, flew drones over the affected areas to study and 3D map the worst hit zones. The information was then passed to rescue workers on the ground to show them exactly where to go.

In Africa, medical deliveries by drone are already underway. US-based startup Matternet has partnered with the government of Malawi and with UNICEF to deliver infant H.I.V. tests within the country and in Rwanda, another start-up, Zipline, is delivering blood and pharmaceuticals to remote locations in hours rather than weeks or months. According to Zipline, its system’s speed makes it possible to maintain a “cold chain” and when it reaches hospitals, they will not land but will drop small packages from very low altitudes. The supplies will fall suspended by simple paper parachutes. The drones will then return to a home base, where they will be prepared for a new mission by swapping in a new battery and snapping in a

new flight plan stored in a SIM card.

Drone deliveries are not only in emerging markets. Within the US, NASA partnered with drone startup business, Flirtey to deliver medicines and other medical supplies to an annual free clinic in Virginia. The entire operation took about two hours as Flirtey separated the medical supplies into 24 small packages which were then transported by the drone. The pharmaceuticals were lowered to the ground via tether and health care professionals at the scene received them.

In Europe, DHL is utilizing drones to deliver drugs and other urgent supplies to a remote island in the North Sea. The island, Juist, is only accessible by a once daily ferry service and regular passenger flights. According to a press statement from a DHL Parcel spokesperson back in 2014, deliveries are secured and all types of drugs can be carried except those which are dependent on refrigeration, as a refrigeration unit may be too weighty for the ‘parcelcopter’ to carry.

Also in Europe, a very interesting product has recently been introduced by Flash, a logistics provider that focuses on premium freight delivery

12

services. Flash’s drone is one of the more unique in the market. Each drone is equipped with biologistic isothermal packaging for temperature control and monitoring and travels on a predefined and programmed flight path directed by longitude and latitude coordinates. Testing is expected to take place this year at the University Hospital Center of Bordeaux, a partner of Drones for Life which is a group of healthcare, technology and development experts trained to route and test drones safely and one in which Flash is a member. The delivery service itself will be marketable in Europe by 2017.

Is drone delivery viable? According to various market research companies, the estimated market size of the commercial drone market was about $609 million in 2014 and is expected to grow roughly to $4.8 to $6.4 billion by 2021. The market faces numerous challenges, most importantly how to share air space with larger airplanes as well as privacy and security concerns. However, its benefits in delivering life-saving pharmaceuticals to remote areas cannot be denied and perhaps this is ‘secret sauce’ within supply chains. But, like many other great innovations, its use will evolve and expand over time to perhaps delivering to the elderly and shut-ins to delivery within ‘smart cities’. The possibilities are endless.

Resources 1. http://pharmaceuticalcommerce.com/supply-chain-logistics/pharmaceutical-cold -chain-logistics-is-a-12-6-billion-global-industry/

2. http://www.prnewswire.com/news-releases/global-insulated-packaging-market-to grow-568-by-2020---increased-demand-from-pharmaceutical-industry---research and-markets-300317680.html

3. http://www.coldchainiq.com/transportation-logistics/columns/drugs-via-drone delivery-%E2%80%93-a-viable-solution

Final Remarks

A clear trend that is pinpointed by our participants is the personalisation of the cold chain. This stretches to encompass the technologies used and the networks being sculpted specifically for the products at hand. A labour intensive task but likely to produce a higher quality of work. Cost control is, unsurprisingly, expected to stand at the front of focus in the future alongside the project to crack the challenging but potentially rewarding emerging markets of the world.

Some progression needs to be made in regards to data management, as even though this tool is seen as vital to the future of the industry, many of our participants noted that the main issues lie within the organisations not using the data to its full capacity.

Acknowledgements

Pharma Logistics IQ thanks all the participants who responded to this survey and reminds those who entered the prize draw to look out for notification on whether you won the competition.

INTERESTED IN CONTINUING THE DISCUSSION?

New for 2017:

Hear exclusive first hand feedback from the Pharma Ocean Freight Working Group Forum - the 2015 Initiative aiming to create best practices for reefer handling.

Overcome the challenge of high value / low volume products: Hear the latest biologic and clinical case studies from the experts from UCB, GE healthcare and Pfizer.

Audit expectations and regulatory experiences – Join the GDP regulatory panel to hear the top reasons for non compliance from the regulators themselves - hear from the USP and the Dutch Healthcare Inspectorate.

Utilise your temperature data to improve your logistics processes and meet GDP quality management requirements - Join our interactive pre–conference day workshops.

VISIT: WWW.TEMPERATURECONTROLLEDLOGISTICS.COM

CALL: +44(0)207 036 1300

EMAIL: [email protected]

http://www.coolchaineurope.com/agenda-mc?utm_source=contentagenda&utm_medium=ad&utm_campaign=-external-ad&utm_term=11399.010_contentagenda

Documents

TEMPERATURE CONTROLLED LOGISTICS: STRATEGIES FOR THE … · temperature and humidity. The characterization of these synthesized human proteins in solution has shown a fragility that